Judge OKs morning-after pill for all ages

NEW YORK TIMES |
April 5, 2013
| Updated: April 5, 2013 9:50pm

This undated image made available by Teva Women's Health shows the packaging for their Plan B One-Step (levonorgestrel) tablet, one of the brands known as the "morning-after pill." In a scathing rebuke of the Obama administration, a federal judge ruled Friday that age restrictions on over-the-counter sales of the morning-after pill are "arbitrary, capricious and unreasonable" and must end within 30 days. The ruling by U.S. District Judge Edward Korman of New York means consumers of any age could buy emergency contraception without a prescription _ instead of women first having to prove they're 17 or older, as they do today. And it could allow Plan B One-Step to move out from behind pharmacy counters to the store counters. (AP Photo/Teva Women's Health)

A federal judge ruled Friday that the government must make the most common morning-after pill available over the counter for all ages, instead of requiring a prescription for girls 16 and younger. In his ruling, he also accused the federal government of "bad faith" in dealing with the requests to make the pill universally available, and said its actions had been politically motivated.

The decision, on a politically controversial subject, comes after a decade-long fight over who should have access to the pill and under what circumstances. It also counteracts an unprecedented move by the Obama administration's Health and Human Services secretary, Kathleen Sebelius, who in 2011 overruled a recommendation by the Food and Drug Administration to make the pill available for all ages without a prescription.

In a decision in a lawsuit filed by advocates, the judge, Edward Korman of U.S. District Court, ruled that the government's refusal to lift restrictions on access to the pill was "arbitrary, capricious, and unreasonable."

Korman ordered the FDA to lift any age and sale restrictions on the pill, Plan B One-Step, and its generic versions, within 30 days.

"More than 12 years have passed since the citizen petition was filed and 8 years since this lawsuit commenced," the judge wrote. "The FDA has engaged in intolerable delays in processing the petition."

He added, "The plaintiffs should not be forced to endure … an exercise that permits the FDA to engage in further delay and obstruction."

No decision on appeal

The FDA and the Department of Health and Human Services declined to comment on the ruling or the judge's harsh criticisms Friday morning or indicate whether the government would appeal.

Scientists, including those at the FDA, have been recommending unrestricted access for years, as have major medical groups.

They contend that the restrictions keep many adolescents and younger teenagers from being able to use a safe drug in a timely way to prevent pregnancy, which carries greater safety risks than the morning-after pill.

In 2011, the FDA commissioner, Dr. Margaret Hamburg, declared Plan B One-Step safe to sell over the counter for all ages. But she was overruled by Sebelius, the Health and Human Services secretary, the first time such a public countermanding had ever occurred.

Sebelius said Plan B's manufacturer had failed to study whether the drug was safe for girls as young as 11, about 10 percent of whom are physically able to bear children. Her decision was widely interpreted in a political context because allowing freer access to adolescents would prompt critics to accuse the Obama administration of supporting sexual activity for girls of that age.

72-hour window

The drug's manufacturer, Teva Pharmaceuticals, had petitioned the FDA for Plan B to be available over the counter as far back as 2003.

Plan B One-Step consists of one pill with the active ingredient levonorgestrel, which can block fertilization if taken within 72 hours of sexual intercourse. It reduces the chance of pregnancy to 1 in 40; without the pill, women have about a 1 in 20 chance of pregnancy after unprotected sex.

Two other drugs - Next Choice and Levonorgestrel Tablets - contain levonorgestrel in a two-pill version.

The judge's order also applies to those drugs, although he said that if the FDA "actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product."